Ethical, Legal, and Social Issues in Health Technology Assessment for Prenatal/Preconceptional and Newborn Screening: A Workshop Report

Potter, Beth K.; Avard, Denise; Entwistle, Vikki; Kennedy, Christine A.; Chakraborty, Pranesh; McGuire, M; Wilson, Brenda J.

doi:10.1159/000153430

Cited by 24 publications

(25 citation statements)

References 91 publications

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“…Regardless of their views on consent, with the exception of one father all parents and health professionals unanimously valued the idea that parents should be fully informed about NBS. 45 As shown in previous research, however, the amount of information needed to achieve this differed between parents, 12,66 even within couples, with parents also differing depending on whether or not they had had previous children. Thus, although there is a uniform ideal goal of being informed, the information needed to achieve this is unlikely to be uniform.…”

Section: Discussionmentioning

confidence: 73%

“…12,19,61 Indeed, one paper suggested that information was valued more than choice. 45 Although effective information provision was seen as central to choice 12 and the quality of the choices made, 62 it was also valued for minimising distress if further testing was required or a diagnosis given. 63 In countries that rely on parents actively seeking further care this was improved if parents were given relevant information.…”

Section: Relevant Informationmentioning

confidence: 99%

“…66,72,79 Asian participants or participants for whom English was not their first language were especially likely to prefer information provision by a health professional. 66 This option has some merit as it has been found to be the most effective way to convey complex information 96 and parents had a higher recall after verbal conversations 45 with midwives. 72 In addition, in a study that reported some of the highest levels of awareness across the literature, the majority of mothers in the sample (34%) had received their information from midwives.…”

Section: Content Of Relevant Informationmentioning

confidence: 99%

“…181 Parents taking part in NBS who feel adequately informed and empowered have reported feeling a duty to inform other family members of the potential risks, correct misperceptions and challenge stigma and misunderstanding more widely in their communities. 181 Within both antenatal screening and NBS there is an increasing recognition of the important role that families and social networks can play in informing parents 45,181 and shaping their choices about and adaptation to screening. 181 Thus, optimising communication is likely to have a much broader impact than the impact on the original target set of parents.…”

Section: What Does This Study Add?mentioning

confidence: 99%

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Provision of information about newborn screening antenatally: a sequential exploratory mixed-methods project

Ulph

Wright

Dharni

et al. 2017

Health Technol Assess

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BackgroundParticipation in the UK Newborn Bloodspot Screening Programme (NBSP) requires parental consent but concerns exist about whether or not this happens in practice and the best methods and timing to obtain consent at reasonable cost.ObjectivesTo collate all possible modes of prescreening communication and consent for newborn (neonatal) screening (NBS); examine midwives’, screening professionals’ and users’ views about the feasibility, efficiency and impact on understanding of each; measure midwives’ and parents’ preferences for information provision; and identify key drivers of cost-effectiveness for alternative modes of information provision.DesignSix study designs were used: (1) realist review – to generate alternative communication and consent models; (2) qualitative interviews with parents and health professionals – to examine the implications of current practice for understanding and views on alternative models; (3) survey and observation of midwives – to establish current costs; (4) stated preference surveys with midwives, parents and potential future parents – to establish preferences for information provision; (5) economic analysis – to identify cost-effectiveness drivers of alternative models; and (6) stakeholder validation focus groups and interviews – to examine the acceptability, views and broader impact of alternative communication and consent models.SettingProviders and users of NBS in England.ParticipantsStudy 2: 45 parents and 37 health professionals; study 3: 22 midwives and eight observations; study 4: 705 adults aged 18–45 years and 134 midwives; and study 6: 12 health-care professionals and five parents.ResultsThe realist review identified low parental knowledge and evidence of coercive consent practices. Interview, focus group and stated preference data suggested a preference for full information, with some valuing this more than choice. Health professionals preferred informed choice models but parents and health professionals queried whether or not current consent was fully informed. Barriers to using leaflets effectively were highlighted. All studies indicated that a ‘personalised’ approach to NBS communication, allowing parents to select the mode and level of information suited to their learning needs, could have added value. A personalised approach should rely on midwife communication and should occur in the third trimester. Overall awareness was identified as requiring improvement. Starting NBS communication by alerting parents that they have a choice to make and telling them that samples could be stored are both likely to enhance engagement. The methods of information provision and maternal anxiety causing additional visits to health-care professionals were the drivers of relative cost-effectiveness. Lack of data to populate an economic analysis, confirmed by value of information analysis, indicated a need for further research.LimitationsThere are some limitations with regard to the range of participants used in studies 2 and 3 and so caution should be exercised when interpreting some of the results.ConclusionsThis project highlighted the importance of focusing on information receipt and identified key communication barriers. Health professionals strongly preferred informed consent, which parents endorsed if they were made aware of sample storage. Uniform models of information provision were perceived as ineffective. A choice of information provision was supported by health professionals and parents, which both enhances cost-effectiveness and improves engagement, understanding and the validity of consent. Remaining uncertainties suggest that more research is needed before new communication modes are introduced into practice. Future research should measure the impact of the suggested practice changes (informing in third trimester, information toolkits, changed role of midwife).Trial registrationCurrent Controlled Trials ISRCTN70227207.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 55. See the NIHR Journals Library website for further project information.

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Section: Discussionmentioning

confidence: 73%

Section: Relevant Informationmentioning

confidence: 99%

Section: Content Of Relevant Informationmentioning

confidence: 99%

Section: What Does This Study Add?mentioning

confidence: 99%

See 2 more Smart Citations

Provision of information about newborn screening antenatally: a sequential exploratory mixed-methods project

Ulph

Wright

Dharni

et al. 2017

Health Technol Assess

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“…Although they are usually intended to take a societal or policy perspective, health technology assessments are often limited by a lack of rigorous data on those "nontechnical" issues that may be important in implementation in practice (Potter et al 2009). For example, Lehoux and Blume (2000) describe the Australian experience of a technology assessment process for cochlear implants that focused on the outcome of decibels of hearing loss restored but failed to appreciate the objections of the Deaf community to what they saw as a socially disruptive intervention.…”

Section: Introductionmentioning

confidence: 99%

Public attitudes towards genomic risk profiling as a component of routine population screening

Nicholls

Wilson

Craigie

et al. 2013

Genome

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Abstract:Including low penetrance genomic variants in population-based screening might enable personalization of screening intensity and follow up. The application of genomics in this way requires formal evaluation. Even if clinically beneficial, uptake would still depend on the attitudes of target populations. We developed a deliberative workshop on two hypothetical applications (in colorectal cancer and newborn screening) in which we applied stepped, neutrally-framed, information sets. Data were collected using nonparticipant observation, free-text comments by individual participants, and a structured survey. Qualitative data were transcribed and analyzed using thematic content analysis. Eight workshops were conducted with 170 individuals (120 colorectal cancer screening and 50 newborn screening for type 1 diabetes). The use of information sets promoted informed deliberation. In both contexts, attitudes appeared to be heavily informed by assessments of the likely validity of the test results and its personal and health care utility. Perceived benefits included the potential for early intervention, prevention, and closer monitoring while concerns related to costs, education needs regarding the probabilistic nature of risk, the potential for worry, and control of access to personal genomic information. Differences between the colorectal cancer and newborn screening groups appeared to reflect different assessments of potential personal utility, particularly regarding prevention.Key words: personalized medicine, screening, public health, evaluation, utility.Résumé : L'inclusion de variants génomiques à faible pénétrance dans des dépistages à l'échelle de populations pourrait permettre une personnalisation de l'intensité du dépistage et de son suivi. Un tel recours à la génomique doit cependant faire l'objet d'une évaluation formelle. Même si bénéfique au plan clinique, l'adoption d'une telle approche dépendrait des attitudes au sein des populations ciblées. Les auteurs ont mis au point un atelier de discussion pour deux applications hypothétiques (dépistage pour le cancer colorectal et chez les nouveau-nés) où ils ont fait appel à des ensembles d'information gradués et neutres. Les données ont été obtenues auprès d'observateurs non-participants, des commentaires écrits produits par les participants individuels et au moyen d'un sondage structuré. Des données qualitatives ont été transcrites et analysées par analyse du contenu thématique. Huit ateliers ont été tenus impliquant un total de 170 individus (120 pour le dépistage du cancer colorectal et 50 pour le dépistage du diabète de type 1 chez les nouveau-nés). L'emploi d'ensembles d'information a favorisé les échanges informés. Dans les deux cas, les attitudes ont semblé fortement influencées par la vraisemblable validité des résultats des tests ainsi que leur utilité en matière de soins. Les bénéfices perçus incluaient la possibilité d'une intervention précoce, la prévention et un suivi plus serré tandis que les inquiétudes concernaient les coûts, la nécessité d'...

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Real-World Data in Health Technology Assessment: Do We Know It Well Enough?

Kang

2022

Human Perspectives in Health Sciences and Technology

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Advanced data science leads the fourth revolution. Data are not only contributing to developing new technologies, but also are expected to help provide scientific and systematic evidence to policymakers by combining all available evidence. In health care, big data and real-world data (RWD) are major key concepts. While they share the similarity, two data are different. As the interests in data being increased, the health technology assessment (HTA) agency faces another phase to incorporate these data in appraising new health technology. This chapter focuses on RWD to discuss the opportunities and challenges of using RWD in HTA. RWD is expected to help supplement the information of survival model, comparators, generalisability and rare cancers along with RCTs. However, there are some limitations to use RWD in HTA, such as no consensus on the definition of RWD, the risk of confounder, challenges to assess the relative treatment effects, quality of data and also generalisability issue. In order to use RWD appropriately in HTA, the deliberation based on the understanding of limitation should be accompanied.

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Ethical, Legal, and Social Issues in Health Technology Assessment for Prenatal/Preconceptional and Newborn Screening: A Workshop Report

Cited by 24 publications

References 91 publications

Provision of information about newborn screening antenatally: a sequential exploratory mixed-methods project

Provision of information about newborn screening antenatally: a sequential exploratory mixed-methods project

Public attitudes towards genomic risk profiling as a component of routine population screening

Real-World Data in Health Technology Assessment: Do We Know It Well Enough?

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